(2002; 166 pages)
Proposed regulations for natural health products in Canada
Dr Peter Chan, Canada
The Natural Health Products Directorate (NHPD) of Canada is committed to ensuring that all Canadians have ready access to natural health products that are safe, effective, and of high quality, while respecting freedom of choice, and philosophical and cultural diversity. Natural health products are defined as natural products used to maintain or promote health, or prevent or treat diseases or conditions. These include listed herbs, homoeopathic and traditional medicines, and substances derived from botanical or animal materials or microorganisms, including isolates. However, natural health products exclude biologicals, tobacco, antibiotics, etc.
The Natural Health Products Regulations cover natural health products. Under these regulations, all natural health products will be licensed and authorized for sale by NHPD. The evidence required for a product licence will depend on the level of claims made for the product and its safety. The evidence might include:
• published monographs;
• prior knowledge about the product;
• additional toxicological data (if required).
As recommended by the Standing Committee on Health, three types of claims will be allowed for natural health products:
• risk reduction;
• treatment (some restrictions may be proposed depending on level of evidence).
In order to ensure safety and quality, all manufacturers, packagers and labellers of natural health products sold in Canada will be licensed, and will be required to employ GMP. Guidance on GMP appropriate for natural health products has been developed. All holders of licences for natural health products will be required to monitor and report any serious adverse reactions to Health Canada.
There will be specific requirements for the labelling of all natural health products, such as the product licence number, lot number, list of ingredients, directions for use and precautions, so as to allow consumers to make informed choices.
The Natural Health Products Directorate will:
• continue to involve stakeholders in the development of natural health products;
• build partnerships in the areas of research, education and awareness of the regulatory framework;
• put the natural health products regulations in the Canada Gazetteer, Part II by the end of 2002.